1. Field of the Invention
The present invention relates generally to the fields of oral and topical pharmaceutical compositions or formulations. More specifically, the present invention relates to gel based oral or dental and topical or dermal pharmaceutical compositions and formulations and methods for their use.
2. Description of the Related Art
Oral health can be defined as the absence of acute or chronic orofacial pain, oral and throat cancer, oral sores, birth defects such as cleft lip or palate defects, periodontal disease, tooth decay, tooth loss, and other diseases and disorders that affect mouth. Oral diseases share risk factors with the four major chronic diseases that affect humans (cardiovascular diseases, cancer, chronic respiratory diseases and diabetes), as are favored by harmful diets, smoking and harmful alcohol consumption. Another risk factor is poor oral hygiene. The most common oral diseases are dental caries and periodontal range of dental caries which affects from 60% to 90% of the population.
Current products for oral hygiene in the market use primarily antibiotics and antimicrobial active ingredients to combat dental bacteria, sometimes referred to as dental “biofilms”. While current products can provide a temporary antiseptic protective effect, adverse effects in the oral cavity and/or systemically can result. For example, chlorhexidine contraindications include use for prolonged periods of time and possible allergic reactions, as well as contraindications with other compounds such as sodium fluoride typically applied as a preventive cariogenic agent. Similarly, the antiseptic Triclosan is less toxic than chlorhexidine but is still undesirably toxic for prolonged use in patients.
Worldwide, it is considered that tooth loss is a natural consequence of aging, but in fact it is preventable. Dental caries is still a problem in developed countries affecting between 60% and 90% of the school population and the vast majority of adults. Tooth decay is the most prevalent oral disease in several Asian and Latin American countries.
Plaque-forming agents number some 700 etiologic microbial genera, including the bacterial flora Streptococcus sanguis, Streptococcus mitis, Streptococcus oralis and Actinomyces naeslundii. These microorganisms are precursors in the formation of dental plaque. Later, other bacteria proliferate such as Streptococcus mutans, Streptococcus salivarius, Streptococcus gordonii, Streptococcus parasanguis, Neisseria spp among others, affecting oral health significantly leading to periodontal diseases. The genesis of dental biofilm is a dynamic and complex process and is difficult to understand in its entirety.
Thus, there is a recognized need for an innovative strategy to protect dental organs and adjacent soft tissues in order to prevent the formation of dental biofilms. The present invention fulfills this longstanding need and desire in the art.